FDA Quality Management System —>QMSR
“On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.” (FDA.gov)
The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.
Want to be ready?
SCHEDULE your annual company internal audit with Followell Compliance Consultants, LLC between June 2024-October 2024. This will give adequate time to make updates to your system if potential gaps are identified in your audit.
Audit Scope:
- Compliance to current 21 CFR 820
- Readiness assessment for QMSR
With your audit report you will be able to address any observations in the 2025 calendar year, in plenty of time before the FDA enforcement date of February 2025.
Who should schedule an internal audit with Followell Compliance Consultants, LLC?
- Wholesale Distributors/Importers/Private Label
- Spec Developers (IP owners) who use 3rd party manufacturers and distributors
- Physical Manufacturers that own and make their own medical devices
- Contract Manufacturers with multiple medical device customers
- Class I 510(k) exempt (but not GMP Exempt) medical device sellers
